Acute-On-Chronic Liver FailurePhase 2A-TANGONCT06890039
A-TANGO Phase 2 Study
A Phase 2 study testing TAK-242 and G-CSF (Filgrastim) in people with Acute-On-Chronic Liver Failure and Alcoholic Hepatitis, run by Yaqrit Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
- What is being tested?
- TAK-242 and G-CSF (Filgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients accepted for inclusion into the study must meet all of the following criteria:
- Male and female subjects ≥18 of age and ≤75 years of age
- Compliance with acceptable contraceptive methods.
- With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of >0.45 and/or in whom steroids are contraindicated.
- Eligible subjects will have Grade 1-3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of >35 and <60.
Who cannot join
- Patients with any of the following criteria are to be excluded:
- Refusal to give informed consent
- Mechanical ventilation due to respiratory failure and/or need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of >0.5ug/kg/min to maintain mean arterial pressure > 70mmHg
- Subject has received any investigational drug within 30 days of randomization
- Subject has any of the following conditions:
- history of liver transplantation
Show all 15Show fewer
- postoperative decompensation after partial hepatectomy
- liver failure without underlying chronic liver injury
- Any untreated infections (<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV.
- Chronic or pre-existing kidney failure, survival prognosis of <6 months due to severe co-morbid conditions that might confound study results or compromise subject safety
- Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia
- Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.
- Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures).
- Pregnancy or nursing women
- Allergy to eggs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital
London, Greater London, NW3 2QG
Abigail Brownlie, MSc, +442077940500 ext. 22522, abigail.brownlie@nhs.net
Raiza Jaafar Jumah, MHA, +442077940500 ext. 22522, raiza.jumah@nhs.net
About this study
Official title: Phase II, Double-blind, Randomized, Placebo-controlled, Multicentre Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TAK-242 and (G-CSF) in Subjects With (sAH) and (ACLF)
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe.
Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a >15% risk of mortality at 28 days.
Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol [severe alcoholic hepatitis (sAH)] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.
Read the detailed description
The purpose of this Phase 2 clinical trial is to investigate
- the safety of TAK-242 alone or in combination with G-CSF (G-TAK) in patients with sAH and ACLF.
- the effect of TAK-242 alone or in combination with G-CSF (G-TAK) on the disease severity of ACLF.
Study design:
Multi-center, randomized, double-blind, placebo-controlled trial. Study drug will be administered while subjects are hospitalized. Patients will have been hospitalized for their underlying disease.
78 patients to be randomized (1:1:1) to one of the following three arms:
- Standard of care (SOC) plus placebo for TAK-242 plus placebo for G-CSF
- Standard of care (SOC) plus continuous IV infusion of TAK-242 for 10 days (Day 1-10) plus placebo for G-CSF.
- Standard of Care (SOC) plus continuous IV infusion of TAK-242 for 10 days (Day 1-10) plus daily subcutaneous G-CSF injections for 5 days (Day 1-5) and at Day 8 (6 injections in total)
Follow-up visits will occur on Day 14 (± 4 d), Day 28 (± 5 d), and Day 84 (± 7d). For each patient, the total duration of subject participation in the study, including screening, will be 86 ± 7 days.
The total study duration is estimated to be approximately 42 months from screening of first patient until study completion of the last patient/last visit and data analysis.
The placebo is the same as the investigational medication but does not contain the active ingredient. A placebo is used to check that any effects seen in people taking part in the study are because of the investigational medications and not due to the underlying disease (for safety) or to spontaneous improvement (for efficacy)
The study will also look at how the investigational medications affect the body (known as "pharmacodynamics") and how your body processes the investigational medications (known as "pharmacokinetics").
Investigational product:
- TAK-242 concentrate for solution for infusion (80 mg/mL in 3 mL ethanol): 240 mg TAK-242 per vial. To be reconstituted with 5% dextrose (36 mL) and commercially available 20% intralipid (21 mL).
- Matching placebo: 5% dextrose solution and commercially available lipid emulsion (prepared in hospital pharmacy
- G-CSF(filgrastim): Commercially available vials for subcutaneous injection. Matching placebo: identical to vehicle for filgrastim (prepared for injection by hospital pharmacist, or equivalent)
Management of patients Management of patients enrolled in the study will be performed according to guidelines and best practice of treatments for the management of complications of cirrhosis derived from international societies. Standard medical therapy also means that patients will be clinically assessed daily, including results of clinical chemistry and blood count.
An independent Data and Safety Monitoring Board (DSMB)will review safety and pharmacokinetic data after randomization of 18 patients (n=6 in each treatment arm) with complete PK analysis through Day 4 (±1 d). The DSMB will assess the relevance of drug-related adverse events and drug-drug interactions.
Compliance with Good Clinical Practices The study will be conducted in accordance with all applicable aspects of GCP. Statistical Analysis of Data The primary endpoint - safety - will be evaluated by descriptive statistics.
Secondary endpoints will offer an indication about potential signals in efficacy for future trials. Sample size was estimated to find differences in CLIF-C OF score between G-TAK and placebo, to allow a 90% statistical power to detect a 1.5-point difference between the combination G-TAK and the SOC arm in the reduction of CLIF-C OF score after 14 days from trial enrolment. A 5% Type-I error for a two-sided Student's t-test with repeated measurements is assumed. This sample size includes a dropout rate of 15%.
- Being tested
- Placebo, TAK-242, G-CSF (Filgrastim)
- Keywords
- Novel combinatorial therapy, Improve hepatocyte proliferation, ACLF, Liver disease
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hepatitis, Alcoholic, Liver Cirrhosis, Alcoholic, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo for TAK-242: 5% dextrose solution and commercially available 20% intralipid (prepared by hospital pharmacy staff)
Matching placebo for G-CSF: identical to vehicle for filgrastim (prepared for injection by hospital pharmacy staff)
TAK-242Drug
TAK-242 concentrate for solution for infusion (80 mg/ mL in 3 mL ethanol) ): 240 mg TAK-242 per vial. To be reconstituted with 5% dextrose (36 mL) and commercially available 20% intralipid (21 mL).
TAK-242) will be administered as a continuous IV infusion starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 10 days.
PLUS placebo for G- CSF
G-CSF (Filgrastim)Drug
Commercially available vials for subcutaneous injection. Quantitative composition (per mL):
Filgrastim: 300 mcg Acetate: 0.59 mg Sorbitol: 50.0 mg Tween® 80: 0.04 mg Sodium: 0.035 mg Water for Injection USP q.s. ad 1.0 mL
G-CSF will be given subcutaneously once daily at a dose of 5 µg/kg for 5 days (Day 1-5) and at Day 8 (6 injections in total)
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SOC) plus placebo for TAK-242 plus placebo for G-CSF | Placebo comparator | Not described Receives: Drug: Placebo |
| Standard of care (SOC) plus TAK-242 plus placebo for G-CSF | Active comparator | Not described Receives: Drug: TAK-242 |
| Standard of Care (SOC) plus TAK-242 plus G-CSF | Active comparator | Not described Receives: Drug: TAK-242; Drug: G-CSF (Filgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of TAK-242 in combination with G-CSF and alone in subjects with sAH and ACLF compared to placebo
To assess the safety of TAK-242 in combination with G-CSF (G-TAK) and alone in subjects with sAH and ACLF compared to placebo from baseline to Day 14:
- The percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) or SAE.
- The percentage of subjects who discontinue the study drug due to an AE (including methemoglobinemia).
Measured: Baseline to Day 14
Secondary outcomes (14)
Changes in CLIF-C OF score
Changes in CLIF-C OF score in subjects treated with G-TAK compared with placebo from baseline to Day 14 CLIF-C OF (Chronic Liver Failure Organ Failure) - The CLIF-C organ failure (OF) score is used to diagnose acute-on-chronic liver failure (ACLF) in patients with acute decompensation of cirrhosis. Each organ system is scored on a scale to generate the overall CLIF-C OF score, ranging from 0 to 18. A higher CLIF-C OF score translates into a higher ACLF grade.
Measured: Baseline to Day 14
Changes in CLIF C ACLF-CRP score
Changes in CLIF-C OF score in patients treated with TAK-242 alone compared with G-TAK and placebo, as well as changes in CLIF C ACLF-CRP score between all arms
CLIF-C Acute-on-chronic liver failure - c-reactive protein (CLIF-C ACLF-CRP) will be calculated using this formula:
CLIF-C ACLF-CRP score = 10 x (0.293 x CLIF-C OF score + 0.034 x Age[years] + 0.292 x log(CRP) - 0.8)
Measured: Baseline to Day 84
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
tmax(hr): Time point where the peak plasma concentration is maximum will be calculated
Measured: Baseline to Day 7
To Investigate the effects of TAK-242 alone or in combination with G-CSF, compared with placebo and between active treatment groups, on key biomarkers for inflammation, cell death, liver function, regeneration and senescence
Changes from baseline after 14 days in naturally log-transformed key liver function biomarkers will include:
- total bilirubin (TB)
- cleaved Cytokeratin-18 (M30)/ Cytokeratin-18 (M65)
- transforming growth factor beta 1 (TGFb1)
- interleukin 22 (IL-22)
- interleukin 22 binding protein (IL-22BP)
- C-reactive protein (CRP)
- hepatic growth factor (HGF)
- stromal cell-derived factor 1 (SDF-1),
- soluble urokinase-type plasminogen activator receptor (suPAR))
- DNA methylation
- circulating RNAs (genes MYLK3, SLC22A13, TPRG1-AS1, AC020633.1, TPRG1-AS1, NUDT4P1 Biomarkers of Humoral Inflammation and Cell Death, Cellular inflammation, regeneration \& senescence, metabolic and genetics and mitochondrial function are assessed individually between treatment groups as well as overall, global trends between treatment groups. They are not aggregated to arrive at one reported value.
Measured: From Baseline to Day 4, 7, and 14
To investigate transplant free and overall survival in subjects with sAH and ACLF
To investigate the effect of TAK-242 alone or the combination of TAK-242 and G-CSF (G-TAK) versus placebo on Day 28 and Day 84 transplant free and overall survival in subjects with sAH and ACLF.
This is not a scale. Patients either do or do not have a liver transplant during the study period; and either survive or don't survive.
Measured: Upto Day 84
Change in organ function between different treatment arms.
Assessments of organ failure, systemic inflammation, and ACLF
Measured: Baseline to Day 14
To investigate the effect on the Quality of Life
To investigate the effect of TAK-242 alone or the combination G-TAK compared with placebo and each other on the Quality of Life in subjects with sAH and ACLF. The scoring system that will be used is EQ5D5L, which allows assessment of QoL changes in sick patients
Quality of Life scale is scored from 0 to 100, with 0 being worst health you can imagine; 100 best health.
Measured: Baseline to Day 84
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
t1/2(hr) will be determined from the terminal phase in plasma after drug administration
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Cmax(ng/mL): highest concentration of a drug in the blood will be calculated
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Steady-state concentration (Cssng/mL) will be calculated for drug being absorbed in the body when the drug is given continuously or repeatedly
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
AUC last (h*ng/ml): Area under curve from pre-dose to the last sampling time-point will be calculated
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
AUC infinity (h*ng/ml): Area under curve from pre-dose to the extrapolated data till the concentration reaches to baseline
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Total body clearance (L/h) will be calculated
Measured: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Total body clearance at steady state (L/h) will be calculated
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start29 Jun 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is randomized, double-blind, and placebo-controlled to avoid subjective bias in the assessment of the study drug. Placebo will be administered as a control in order to establish the frequency or magnitude of changes in clinical endpoints that may occur with standard supportive care, in the absence of active experimental treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaqrit Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Foundation for Study of Chronic Liver Failure, University College, London, HEPYX LIMITED, CROWDHELIX LIMITED, Charite University, Berlin, Germany, University of Leipzig, Concentris research management gmbh, Assistance Publique - Hôpitaux de Paris, Leiden University Medical Center, INTERNATIONAL MARKET ACCESS CONSULTING GMBH, KlinEra Global Services, European Association for the Study of the Liver, European Liver Patients' Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890039
- Sponsor's protocol ID
- G-TAK-ES-01
- Other IDs
- 945096, 2022-000128-39, 1005490
- Acronym
- A-TANGO
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double-blind, Randomized, Placebo-controlled, Multicentre Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TAK-242 and (G-CSF) in Subjects With (sAH) and (ACLF)
- ClinicalTrials.gov ID
- NCT06890039
- Acronym / sponsor ID
- A-TANGO / G-TAK-ES-01
- Keywords
- Novel combinatorial therapy, Improve hepatocyte proliferation, ACLF, Liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Yaqrit LtdIndustry (pharma, biotech, devices)
- Collaborators
- European Foundation for Study of Chronic Liver Failure, University College, London, HEPYX LIMITED, CROWDHELIX LIMITED, Charite University, Berlin, Germany, University of Leipzig, Concentris research management gmbh, Assistance Publique - Hôpitaux de Paris, Leiden University Medical Center, INTERNATIONAL MARKET ACCESS CONSULTING GMBH, KlinEra Global Services, European Association for the Study of the Liver, European Liver Patients' Association
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe.
Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a >15% risk of mortality at 28 days.
Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol [severe alcoholic hepatitis (sAH)] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.
Detailed description
The purpose of this Phase 2 clinical trial is to investigate
- the safety of TAK-242 alone or in combination with G-CSF (G-TAK) in patients with sAH and ACLF.
- the effect of TAK-242 alone or in combination with G-CSF (G-TAK) on the disease severity of ACLF.
Study design:
Multi-center, randomized, double-blind, placebo-controlled trial. Study drug will be administered while subjects are hospitalized. Patients will have been hospitalized for their underlying disease.
78 patients to be randomized (1:1:1) to one of the following three arms:
- Standard of care (SOC) plus placebo for TAK-242 plus placebo for G-CSF
- Standard of care (SOC) plus continuous IV infusion of TAK-242 for 10 days (Day 1-10) plus placebo for G-CSF.
- Standard of Care (SOC) plus continuous IV infusion of TAK-242 for 10 days (Day 1-10) plus daily subcutaneous G-CSF injections for 5 days (Day 1-5) and at Day 8 (6 injections in total)
Follow-up visits will occur on Day 14 (± 4 d), Day 28 (± 5 d), and Day 84 (± 7d). For each patient, the total duration of subject participation in the study, including screening, will be 86 ± 7 days.
The total study duration is estimated to be approximately 42 months from screening of first patient until study completion of the last patient/last visit and data analysis.
The placebo is the same as the investigational medication but does not contain the active ingredient. A placebo is used to check that any effects seen in people taking part in the study are because of the investigational medications and not due to the underlying disease (for safety) or to spontaneous improvement (for efficacy)
The study will also look at how the investigational medications affect the body (known as "pharmacodynamics") and how your body processes the investigational medications (known as "pharmacokinetics").
Investigational product:
- TAK-242 concentrate for solution for infusion (80 mg/mL in 3 mL ethanol): 240 mg TAK-242 per vial. To be reconstituted with 5% dextrose (36 mL) and commercially available 20% intralipid (21 mL).
- Matching placebo: 5% dextrose solution and commercially available lipid emulsion (prepared in hospital pharmacy
- G-CSF(filgrastim): Commercially available vials for subcutaneous injection. Matching placebo: identical to vehicle for filgrastim (prepared for injection by hospital pharmacist, or equivalent)
Management of patients Management of patients enrolled in the study will be performed according to guidelines and best practice of treatments for the management of complications of cirrhosis derived from international societies. Standard medical therapy also means that patients will be clinically assessed daily, including results of clinical chemistry and blood count.
An independent Data and Safety Monitoring Board (DSMB)will review safety and pharmacokinetic data after randomization of 18 patients (n=6 in each treatment arm) with complete PK analysis through Day 4 (±1 d). The DSMB will assess the relevance of drug-related adverse events and drug-drug interactions.
Compliance with Good Clinical Practices The study will be conducted in accordance with all applicable aspects of GCP. Statistical Analysis of Data The primary endpoint - safety - will be evaluated by descriptive statistics.
Secondary endpoints will offer an indication about potential signals in efficacy for future trials. Sample size was estimated to find differences in CLIF-C OF score between G-TAK and placebo, to allow a 90% statistical power to detect a 1.5-point difference between the combination G-TAK and the SOC arm in the reduction of CLIF-C OF score after 14 days from trial enrolment. A 5% Type-I error for a two-sided Student's t-test with repeated measurements is assumed. This sample size includes a dropout rate of 15%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is randomized, double-blind, and placebo-controlled to avoid subjective bias in the assessment of the study drug. Placebo will be administered as a control in order to establish the frequency or magnitude of changes in clinical endpoints that may occur with standard supportive care, in the absence of active experimental treatment.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SOC) plus placebo for TAK-242 plus placebo for G-CSF | Placebo comparator | Drug: Placebo |
| Standard of care (SOC) plus TAK-242 plus placebo for G-CSF | Active comparator | Drug: TAK-242 |
| Standard of Care (SOC) plus TAK-242 plus G-CSF | Active comparator | Drug: TAK-242, Drug: G-CSF (Filgrastim) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients accepted for inclusion into the study must meet all of the following criteria:
Key exclusion criteria (15 listed)
- Patients with any of the following criteria are to be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo for TAK-242: 5% dextrose solution and commercially available 20% intralipid (prepared by hospital pharmacy staff) Matching placebo for G-CSF: identical to vehicle for filgrastim (prepared for injection by hospital pharmacy staff) | Drug | Standard of care (SOC) plus placebo for TAK-242 plus placebo for G-CSF |
| TAK-242TAK-242 concentrate for solution for infusion (80 mg/ mL in 3 mL ethanol) ): 240 mg TAK-242 per vial. To be reconstituted with 5% dextrose (36 mL) and commercially available 20% intralipid (21 mL). TAK-242) will be administered as a continuous IV infusion starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 10 days. PLUS placebo for G- CSF | Drug | Standard of Care (SOC) plus TAK-242 plus G-CSF, Standard of care (SOC) plus TAK-242 plus placebo for G-CSF |
| G-CSF (Filgrastim)Commercially available vials for subcutaneous injection. Quantitative composition (per mL): Filgrastim: 300 mcg Acetate: 0.59 mg Sorbitol: 50.0 mg Tween® 80: 0.04 mg Sodium: 0.035 mg Water for Injection USP q.s. ad 1.0 mL G-CSF will be given subcutaneously once daily at a dose of 5 µg/kg for 5 days (Day 1-5) and at Day 8 (6 injections in total) | Drug | Standard of Care (SOC) plus TAK-242 plus G-CSF |
Primary outcome
To assess the safety of TAK-242 in combination with G-CSF and alone in subjects with sAH and ACLF compared to placebo
Time frame: Baseline to Day 14
To assess the safety of TAK-242 in combination with G-CSF (G-TAK) and alone in subjects with sAH and ACLF compared to placebo from baseline to Day 14: * The percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) or SAE. * The percentage of subjects who discontinue the study drug due to an AE (including methemoglobinemia).
14 secondary outcomes
Changes in CLIF-C OF score
Time frame: Baseline to Day 14
Changes in CLIF C ACLF-CRP score
Time frame: Baseline to Day 84
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
To Investigate the effects of TAK-242 alone or in combination with G-CSF, compared with placebo and between active treatment groups, on key biomarkers for inflammation, cell death, liver function, regeneration and senescence
Time frame: From Baseline to Day 4, 7, and 14
To investigate transplant free and overall survival in subjects with sAH and ACLF
Time frame: Upto Day 84
Change in organ function between different treatment arms.
Time frame: Baseline to Day 14
To investigate the effect on the Quality of Life
Time frame: Baseline to Day 84
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Pharmacokinetics parameters for TAK-242 along with its two main metabolites and G-CSF
Time frame: Baseline to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
RecruitingPhase 2
A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Liver Cirrhosis, Decompensated Cirrhosis of Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-242 and G-CSF (Filgrastim) in people with Acute-On-Chronic Liver Failure and Alcoholic Hepatitis, run by Yaqrit Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Razdan (+917045561443, monica.razdan@klinera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of TAK-242 in combination with G-CSF and alone in subjects with sAH and ACLF compared to placebo (time frame: Baseline to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.